Five mistakes to avoid in the proposals for the ATMP manufacturing HORIZON-HLTH-2025-01-IND-01 call topic
23rd June 2025 at 2:13 pm
With the market for Advanced Therapy Medicinal Products (ATMPs) accelerating across Europe, Horizon Europe is offering targeted support for their manufacturing optimisation. The single-stage call HORIZON-HLTH-2025-01-IND-01 is an Innovation Action (IA) focused on breakthrough process innovation in the ATMP lifecycle from quality control and scale-up to regulatory readiness and sustainable production. Yet with only five projects likely to be funded, avoidable missteps in scope, impact and execution can lead to rejection. Here are the top five mistakes to avoid when preparing your proposal for the 16 September 2025 deadline.
1. Failing to align with the ATMP definition and scope
One frequent error is a vague or misaligned concept of what qualifies as an ATMP under Regulation (EC) No 1394/2007. Don’t assume your therapy qualifies:
- Specify which type of ATMP your project addresses (gene therapy, somatic-cell therapy, or tissue-engineered product).
- Proposals may only cover one ATMP category. Combining multiple types is not in scope.
- Use EMA’s official guidance and classification system to justify your ATMP type (see EMA ATMP overview).
Pro tip: Stay within the lines: proposals must target one ATMP type only. Align early with EMA classification guidance to avoid eligibility risks and ensure a sharp manufacturing focus that evaluators can easily assess.
2. Overlooking platform potential and digital integration
The work programme expects proposals to design an improved manufacturing process that explores platform technologies and digital enablers such as AI, robotics or modelling tools.
What to include:
- Computational modelling, digital twins or AI-driven control systems to optimise process variables
- Evidence of platform scalability and reusability across different ATMPs
- Automation or robotics to reduce manual handling and improve reproducibility
Common pitfall: Failing to show measurable impact of these technologies. Evaluators want to see not just innovation, but cost, time and quality gains over current methods.
3. Weak demonstration of scalability and patient-centred deployment
This call is not about blue-sky research but about getting ATMPs to patients faster and more reliably. Many proposals fail to show:
- Realistic deployment models, especially in decentralised settings like hospital-based manufacturing
- Clinical translation pathways, even if clinical trials are not compulsory
- Stakeholder engagement, especially with the medical community and hospitals
Pro tip: Link your proposal to healthcare needs and demonstrate how your process will be adopted by hospitals or health providers. Consider involving JOIN4ATMP for complementary synergies.
4. Neglecting regulatory and standardisation alignment
A major evaluation weakness is when projects do not address regulatory utility or strategy. Avoid this by:
- Describing your regulatory strategy from the outset
- Explaining how you will produce regulatory-grade data, e.g. standardised potency assays
- Including early engagement plans with regulatory authorities and notified bodies
- Considering involvement of the Joint Research Centre (JRC) as an interface to regulatory science
Pro tip: The JRC’s participation can add credibility, help connect research with regulatory science and support the development of strategies and frameworks that meet regulatory requirements.
5. Underestimating the importance of real-world deployment and SME involvement
Many proposals fall short by treating demonstration and SME involvement as optional. Both are essential to maximise impact. You should:
- Validate ATMP manufacturing improvements in real-world or clinically relevant environments. Proposals that fail to demonstrate pilot deployment or application risk falling short on impact.
- Include SME and industrial participation. Not involving industrial partners with a clear route to market for a first deployment in the EU may significantly weaken your proposal’s credibility and exploitation potential.
Pro tip: Strengthen your proposal by embedding SME partners with market-ready solutions and demonstrating how your innovation will be tested in settings that reflect actual manufacturing or clinical conditions.
Changes in the new Part B template
Please note the following when getting started with your proposal preparation: As of the latest updates to the Horizon Europe RIA/IA proposal template (Part B, v4.0 from December 2024), several noteworthy adjustments have been made. The guidance notes under Section 1.2 Methodology concerning the Do No Significant Harm (DNSH) principle and the technical robustness of AI have been removed. Additionally, the requirements on data management have been simplified: the dedicated Research Data Management chapter has been eliminated and, instead, a brief reference to the Data Management Plan (DMP) has been integrated under the Open science practices section, streamlining the treatment of research data. On a positive note, the template now includes a new, direct link to the EU’s sex and gender reference documentation, making it easier for applicants to ensure appropriate integration of sex/gender dimensions in their research. These changes reflect a simplification and targeted focus in the current template structure.
For more information or general advice on the call topic, please consult your National Contact Point.
Want to position your ATMP project for success?
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Since our foundation, we have been collaborating with more than 1,000 organisations in Europe and beyond. Our successful Research and Innovation Actions (RIAs and IAs) in Health include the recently started Horizon Europe Cluster 1 project EXPOSIM and several other HORIZON projects EDiHTA, EU PAL-COPD, GLIOMATCH, COVend and MyPath. Our Horizon 2020 health projects are still going strong, including the Health projects AI-Mind and EXIMIOUS, and many health-focused Innovative Training and Doctoral Networks, including CAPSTONE, MITGEST and MobiliTraIN.
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